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TerminatedNCT00208221Updated Nov 8, 2007

Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes

A Phase 3 interventional study of ramipril and ramipril-telmisartan in Hypertension, Type 2 Diabetes and Albuminuria, sponsored by Institut de Recherches Cliniques de Montreal. Terminated at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-11-08.

Sponsored by Institut de Recherches Cliniques de Montreal · Phase 3, Interventional, and Treatment

Why this study was terminated
Not enough recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to determine if a dose of ramipril combined with a normal dose of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria in hypertensive patients with diabetes.

Read the detailed description

The purpose of this study is to determine the effects of ramipril 10 mg and telmisartan 80 mg versus ramipril 20 mg in patients with diabetes type II, hypertension and microalbuminuria (Urinary-albuminuria creatinine ratio of 2.0 to 25 mg/mmol) on

  1. Microalbuminuria
  2. Blood pressure (systolic, diastolic and ABPM), Renin-angiotensin system, Catecholamines, Oxydative stress
  3. Comparison at 4, 8 and 12 weeks with addition of hydrochlorothiazide 12.5 mg if BP over 130/80 mmHg
02

Conditions studied

  • Hypertension
  • Type 2 Diabetes
  • Albuminuria

Keywords

  • Hypertension
  • Diabetes
  • Microalbuminuria
  • Blood pressure
03

In context

Albuminuria

121 studies on the registry are indexed under Albuminuria; 21 are open to participants now.

This study's planned enrollment of 50 is below the median of 73 across 96 interventional studies indexed under Albuminuria.

Browse Albuminuria studies →

Lead sponsor

Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female over the age of 18 years
  • Diastolic blood pressure (DBP) greater tha 80 mmHg and less than 104 mmHg
  • Type II diabetes on diet or oral hypoglycemic agents with a hemoglobin A1C (HbA1C) less than 0.080
  • UA ratio albumin:creatinine 2.0 to 25 mg/mmol

Exclusion criteria

Exclusion Criteria:

  • DBP > 104 mmhg
  • Woman not surgically sterile or menopausal.
  • Premenopausal women whoo are not surgically sterile or who are not practicing acceptable means of birth control and do not agree to submit to periodic pregnancy tests.
  • Known or secondary forms of hypertension.
  • Intolerance to angiotensin (AT) 1 receptor blockers or angiotensin-converting enzyme (ACE) inhibitors.
  • Hepatic or renal dysfunction. Creatinine > 150 umol or enzymes greater than 2 times upper limit of normal.
  • Hemodynamically significant renal artery stenosis, renal artery stenosis on a solitary kidney, post-renal transplant or with only one kidney.
  • Uncorrected volume depletion.
  • Biliary obstructive disorders.
  • NYHA functional class congestive heart failure (CHF) III-IV.
  • Coronary heart disease needing pharmacological therapy.
  • Stroke within the preceding six months.
  • Percutaneous transluminal coronary angioplasty (PTCA) within the preceding three months.
  • History of angioedema.
  • Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical investigator.
  • Second or third degree AV block, left bundle branch block or any clinically relevant conduction abnormality as determined by the clinical investigator.
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  • Administration of digoxin.
  • Patients with a fasting glucose greater than 7.0
  • History of drug or alcohol dependency.
  • Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, alpha-blockers, beta-blockers, calcium channel antagonists, direct vasodilators that cannot be stopped for the trial.
  • Administration of other non-antihypertensive medications known to affect blood pressure (e.g. oral corticosteroids, monoamine oxidase [MAO] inhibitors, nitrates) at any time during the trial.
  • Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions.
  • Uncorrected sodium depletion as defined by a serum sodium level less than 135 mEq/L.
  • Clinically significant hyperkalemia as defined by serum potassium level greater than 5.2 mEq/L. Clinically significant hypokalemia as defined by serum potassium level less than 3.0 mEq/L.
  • Patients receiving any investigational therapy within one month of signing the informed consent form.
  • Known hypersensitivity to any component of telmisartan, ramipril or hydrochlorothiazide.
  • Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication.
  • Blood donation in the preceding 1 month.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Drugramipril
  • Drugramipril-telmisartan
06

What researchers measure

Primary outcomes

  1. Microalbuminuria

Secondary outcomes

  1. Plasma renin

  2. plasma angiotensin

  3. plasma aldosterone

  4. plasma catecholamines

  5. oxydative stress

  6. diastolic blood pressure

  7. systolic blood pressure

07

Study locations

1 site
  • Institut de Recherches Cliniques de Montreal
    Montreal, Quebec J4X 1J3, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00208221
Lead sponsor
Institut de Recherches Cliniques de Montreal
First posted
Sep 21, 2005
Start date
Aug 2006
Completion
Jun 2007
Last update
Nov 8, 2007

Study contacts

Pierre Larochelle, MD PhD FRCPC
principal investigator · Institut de Recherches Cliniques de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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